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1 brevetto US5, 191,899-USA SANOLIFE

2 brevetto US5, 191,899-USA SANOLIFE Pap- Test Pap- Test, an irreplaceable practice, but difficult in collecting the cell samples

3 brevetto US5, 191,899-USA SANOLIFE Efficacy of cervical-smear collection devices: a systematic review and meta-analysis The Lancet, 1999, reports that the percentage of false negatives is 55%, caused by sampling errors given the type of device that was used. Moreover, the Ayre spatula is not suitable for taking endocervical cell samples nor from the transformation zone, and is not effective in detecting epithelial glandular neoplasia, and therefore the samples are inadequate, which leads to increased costs and causes anxiety in the patient who has to repeat her pap test. Finally, from a comparison between the following devices: Ayre spatula, Extended tip spatula, Cotton swab, Cytobrush and Cervexbrush, it has been shown that none of them are effective in taking endocervical cells and they determine a high proportion of abnormal cytology.

4 brevetto US5, 191,899-USA SANOLIFE Bibliography G. Guida. D. de Aloysio - L'evoluzione qualitativa del pap test cervicale dalla spatola di Ayre all'Exact Touch Riv. It. Ost. Gin. Giugno 2007 - Vol. 14 M. Cenci, C. Midulla, P. De Iorio, A. Vecchione. Exact Touch : a new single sampler for the uterine cervix. Acta Cytologica volume 43 n. 6 novembre - dicembre 1999 M. Cenci, A. Vecchione. Usefulness of Cervical Collection by the Exact Touch, the Saccomanno Single Sampler, Combined with Automated-Primary Screening. Diagnostic Cytopathology 2000 Vol.23; n. 3 pag.242-244 (volume del mese di ottobre). G. De Palo, B. Stefanon, L. Alasio, S. Pilotti. Exact Touch: a new device for cervical cytology: Comparison with Ayre spatola plus Cytobrush. Cytopathology 2000 aprile 18; Vol 11: pag 322-325. M. Cenci, A. Vecchione. The false negative smear facts and solution. Atti di I.F.C.P.P. Buenos Aires, 7-11 Novembre 1999

5 brevetto US5, 191,899-USA SANOLIFE Technical Data Sheet Exact Touch is formed of a hygienically protected kit that contains: A plastic three-arm sampling device with soft bristles that enables simultaneous eso- and endocervical sampling by means of a simple rotation. A slide. A semi-rigid container for identifying the patient, storing and sampling the biological material. A fixative spray.

6 brevetto US5, 191,899-USA SANOLIFE Exact-Touch is an upside-down T-shaped flexible plastic device, designed for pap tests and simultaneous collection of the endo- and esocervical cells from the neck of the uterus. The hygienically protected kit contains the Exact Touch device, a sample slide, a spray for fixing 50 samples, and an identification case that is also used to transport the biological material.

7 brevetto US5, 191,899-USA SANOLIFE The shape of Exact Touch distinguishes it from other commonly used sampling devices. In particular, the stem has a series of perpendicular branches that make it similar to the cytobrush in collecting the endocervical cells, but it differs for the depth it reaches inside the endocervix which is limited by the side arms, which enable the esocervical cell collection, as they have a curved shape that adapts to the anatomic convexity of the esocervix. The sampling area of the esocervix is limited to the size of the diameter given by the two side arms on the device.

8 brevetto US5, 191,899-USA SANOLIFE Exact-Touch, made in Italy by S A N O L I F E – MILAN. With patent US5,191,899-USA, it is now the most efficient method for collecting cells from the neck of the uterus (portio eso-collar, cervical endocollar canal), and thanks to the preset position of the two horizontal arms, it ensures that no endo-cavity material is collected.

9 brevetto US5, 191,899-USA SANOLIFE The introduction of the long arm of the T into the cervical canal and the contact of the short arms against the portio followed by a 360° rotation (during rotation no pressure is madeagainst the uterine neck, the arms just delicately touch it), enables collecting abundant material, which once it is smeared and fixed onto the slide is ready for sending to the cytologist for the next test phases.

10 brevetto US5, 191,899-USA SANOLIFE The smear should be placed on the slide lengthways, so that the esocervical cells are found on the two side areas of the slide and the endocervical cells in the centre. Furthermore, there is no loss of cells over the edges of the slide.

11 brevetto US5, 191,899-USA SANOLIFE If there are any suspicious vaginal zones, or vaginal samples have to be taken, the spatula shaped end of the Exact Touch can be used, and the sample then smeared and fixed onto the slide.

12 brevetto US5, 191,899-USA SANOLIFE Comparison with other methods In the transformation zone that may be present in the portio, virtually none of the more commonly used spatulas, in wood or plastic, enable complete and satisfactory contact with this zone due to the particular shape of the sampler end. Only the end of the Exact Touch spatula, if used correctly, enables taking and abundant and suitable cell sample from the transformation zone.

13 brevetto US5, 191,899-USA SANOLIFE Economic advantage In relation to the cost-benefit economic aspect, it must be remembered that the Exact Touch kit, hygienically protected, contains the sampling device, the sample slide, the fixative spray and a semi-rigid container for identifying the patient, storing and transporting the sample, and therefore eliminates the need for other sampling components, like the wood or plastic spatula, the cotton swabs or cytobrush, the fixative (liquid or spray) and the indispensable wood or stiff cardboard containers.

14 brevetto US5, 191,899-USA SANOLIFE Obviously this all helps reduce the cost of the procedure, because all the other components used until now are superfluous, as the kit contains everything that is needed. In relation to the slide containers, especially if multiple slides are involved, we should remember that these are often the cause for exchanges, accidental replacement or confusion among slides from patients in different locations. Furthermore, the kit saves time in the various sampling phases, does not cause suffering to the patient, collects abundant test material, eliminates improper smears with “build up” of cells, but prepares a “single layer smear”, thus preventing the frequent need to repeat the test.

15 brevetto US5, 191,899-USA SANOLIFE “….quick, practical and effective, given the positive opinion we received from our cytology department regarding the quality of the cervical samples that were obtained….” (Niguarda Hospital Cà Granda) “….Able to “reduce the number of inadequate smears and increase the reliability of the cytological sample…” (University of Bari). “…. To support the request, it must be remembered that colpocytology is, still today, the only diagnostic aid in preventing cervical carcinoma and its prior stages, and also the related STD, enabling us to screen the female population, while respecting the cost- benefit ratio excellently. However, this method has a high percentage of false negatives, which is considerably reduced with this device. Therefore the kit can be considered irreplaceable.” (Seconda University of Naples).

16 brevetto US5, 191,899-USA SANOLIFE “…the kit enables reducing the cost of the sampling and fixing procedure, because it does not require the other components previously needed as they are all grouped in the same kit. Furthermore, the kit saves time in the various sampling phases, collects abundant test material… the unique product made and marketed in Italy by Health Care Supplies.” (Regione Calabria Azienda Ospedaliera Bianchi-Melacrino-Morelli)

17 brevetto US5, 191,899-USA SANOLIFE “we have evaluated the Exact Touch pap test device, distributed exclusively in Italy and Europe by Health Care Supplies… It is an innovative instrument with respect to all the other devices available on the market for the same purpose ….” (USL Bari/2)

18 brevetto US5, 191,899-USA SANOLIFE Exact Touch offers the following advantages It produces single layer smears. Sampling is quick with virtually no bleeding. Reduced patient discomfort. The number of endocervical and metaplastic cells that can be collected from the columnar squama junction with Exact Touch is higher than those collected using the Ayre Spatula and Cytobrush (69.47% with Exact Touch, against 32.97% with Ayre Cytobrush).

19 brevetto US5, 191,899-USA SANOLIFE Exact Touch has the following advantages Exact Touch has a soft slender endocervical arm that is easy to introduce into the endocervical canal, and the side arms touch the cervix and enable better samples of endocervical cells and from the transformation zone (adequate and representative cell samples from the columnar squama junction and the endocervical canal are essential to prevent false negatives). The cell material is smeared in the centre of the slide (meaning there are no cells along the edges) with improved reading by the pathologist. Exact Touch reduces the number of unsatisfactory slides, and therefore reduces the need to repeat the pap test the following month.

20 brevetto US5, 191,899-USA SANOLIFE Screening ASL Pavia (MI) slide reading San Paolo Hospital "University of Milan, Faculty of Anatomy and Pathological Histology” Director: Prof. Guido Coggi. Inadequate samples for diagnostics. In October 0.35% of the samples (4 out of 1143). Very few, and the cause for their inadequacy was due to the slides being broken during transport. Milano, 21 novembre 2005

21 brevetto US5, 191,899-USA SANOLIFE Preparati citologici cervico-vaginali allestiti mediante prelievo con sistema “Exact-Touch”

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